Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)

NCT ID: NCT05606198

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

641407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-06-19

Brief Summary

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The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. The aim of the study is therefore to monitor the onset of autoimmune diseases in a large observational study consisting of German health insurance data.

Detailed Description

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SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand how the virus might effect the working of the Immune system a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID-19.

The basic question concerns the burden of the Post-COVID condition. The study investigate which autoimmune diseases or groups of autoimmune diseases are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in subgroups of the population.

Conditions

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Virus Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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COVID

641,407 patients with a SARS-CoV-2 infection in the year 2020.

Exposed to a SARS-CoV-2 infection

Intervention Type OTHER

The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.

Non-COVID

Matched patients with no SARS-CoV-2 infection during the study period.

No interventions assigned to this group

Interventions

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Exposed to a SARS-CoV-2 infection

The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the year 2020
* Continuously insured with the respective health insurance between 2019-01-01/birth and 2021-06-30/death

Exclusion Criteria

* Only an outpatient or inpatient diagnosis of COVID-19 without laboratory detection of the virus( ICD-10:U07.2!) till 30th of June 2021
* At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the first half of the year 2021
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH

UNKNOWN

Sponsor Role collaborator

BARMER Institut für Gesundheitssystemforschung (bifg)

UNKNOWN

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

DAK Gesundheit

OTHER

Sponsor Role collaborator

AOK PLUS

INDUSTRY

Sponsor Role collaborator

IKK Classic

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Falko Tesch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Schmitt, MD, MPH

Role: STUDY_DIRECTOR

Center for Evidence-Based Healthcare, Technische Universität Dresden

Locations

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Center for Evidence-Based Healthcare, Technische Universität Dresden

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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Tesch F, Ehm F, Vivirito A, Wende D, Batram M, Loser F, Menzer S, Jacob J, Roessler M, Seifert M, Kind B, Konig C, Schulte C, Buschmann T, Hertle D, Ballesteros P, Bassler S, Bertele B, Bitterer T, Riederer C, Sobik F, Reitzle L, Scheidt-Nave C, Schmitt J. Incident autoimmune diseases in association with SARS-CoV-2 infection: a matched cohort study. Clin Rheumatol. 2023 Oct;42(10):2905-2914. doi: 10.1007/s10067-023-06670-0. Epub 2023 Jun 19.

Reference Type BACKGROUND
PMID: 37335408 (View on PubMed)

Other Identifiers

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POINTED-AD

Identifier Type: -

Identifier Source: org_study_id

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